The following data is part of a premarket notification filed by Paradigm Spine, Llc with the FDA for Dds Stabilization System.
| Device ID | K080241 |
| 510k Number | K080241 |
| Device Name: | DDS STABILIZATION SYSTEM |
| Classification | Posterior Metal/polymer Spinal System, Fusion |
| Applicant | PARADIGM SPINE, LLC 1331 H STREET NW 12TH FLOOR Washington, DC 20005 |
| Contact | Justin Eggleton |
| Correspondent | Justin Eggleton PARADIGM SPINE, LLC 1331 H STREET NW 12TH FLOOR Washington, DC 20005 |
| Product Code | NQP |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-31 |
| Decision Date | 2008-11-28 |
| Summary: | summary |